A Phase 3 interventional study of Multimodal Bundle Drugs and Operative Cystoscopy in Interstitial Cystitis, Levator Spasm and Bladder Pain Syndrome, sponsored by Jocelyn Fitzgerald. Terminated at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Jocelyn Fitzgerald · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. The participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. This study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.
Objectives:
The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an Urogynecology clinic.
Primary Aim:
To compare pre and post intervention self-evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi-disciplinary, bundled care compared with usual care in a Urogynecology clinic setting.
Secondary Aims:
a) To identify and phenotype "non-responders" to a bundled approach to Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain (IC/PBS/CPP).
Hypothesis: We hypothesize that a bundled, multidisciplinary care approach will significantly improve patient scores on validated outcomes questionnaires compared to usual care.
Methods:
All treatment plans, medications, and procedures recommended for patients involved in this study are within the current standards of care for IC/PBS/CPP, regardless of treatment arm and are known to be safe interventions.
Study Design: Single center, randomized pre-post intervention/prospective cohort study32 of usual FPMRS care vs. multimodal, multidisciplinary care bundle (MMCB).
Setting: Patients will be recruited from an outpatient Urogynecology clinic. They will subsequently be randomized to a Multidisciplinary chronic pelvic pain clinic at an alternate site vs. continuing usual outpatient care in Urogynecology as above.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 26 is below the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →This is the only study on the registry with Jocelyn Fitzgerald as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Active pelvic or bladder infection within past 2 weeks
Note: patients are not excluded for currently taking any medication on the treatment list.
Patients can be treated for UTI during the study period.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Components of multimodal care bundle 1. MD Evaluation 2. On site pelvic floor physical therapy 3. Behavioral health consult with appropriate psychiatric referrals/treatments 4. Central sensitization/neurogenic pain: Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS: Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)
Drug: Multimodal Bundle Drugs · Procedure: Operative Cystoscopy · Behavioral: Behavioral health consultation/therapy · Other: Pelvic floor physical therapy · Drug: Bladder Instillation · Drug: Vaginal estrogen · Drug: Methenamine · Drug: Amitriptyline/Gabapentin
IC/PBS treatments as directed by Urogynecology specialist
Other: Usual Urogynecologic care
multimodal pain therapy
Also known as: Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)
Evaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate
Patient to see behavioral health/psychiatric care
Patient to have evaluation and treatment by a trained pelvic floor physical therapist
Usual care from practicing academic Urogynecologist
Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin
Topical vaginal estradiol application
UTI prevention/bladder therapeutic
Drug pages: Amitriptyline · Gabapentin
Part of multimodal pain therapy
--O'Leary Sant Questionnaire (OLS), Comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Change at 12 Weeks From Baseline
This survey assesses IC/BPS symptoms and a change in \> or equal to 4 points is considered clinically significant. A higher score change indicates less pain and urinary symptoms. The minimum possible score is 0. The maximum possible score is 37.
Time frame: Baseline, 12 weeks
Healthcare Encounters Motivated on Pain
Number of encounters with the UPMC healthcare system that include emergency room visits, provider calls, provider visits, procedures, and other treatments based on documentation within their medical record.
Time frame: Baseline to 12-month
Chronic Pelvic Pain Study, UPMC Magee's Women's Hospital, Recruited from 12/6/2022 to 9/25/2024
| Milestone | Multimodal Care Bundle | Usual Care |
|---|---|---|
| Started | 16 | 10 |
| Baseline visit and survey completion | 15 | 8 |
| 6-week visit and survey completion | 7 | 7 |
| 12-week visit and survey completion | 7 | 6 |
| 6-month visit and survey completion | 4 | 5 |
| 1-year visit and survey completion | 4 | 5 |
| Completed | 7 | 5 |
| Not completed | 9 | 5 |
This survey assesses IC/BPS symptoms and a change in \> or equal to 4 points is considered clinically significant. A higher score change indicates less pain and urinary symptoms. The minimum possible score is 0. The maximum possible score is 37.
| O' Leary Sant Score | Multimodal Care Bundle | Usual Care |
|---|---|---|
| --O'Leary Sant Questionnaire (OLS), Comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Change at 12 Weeks From Baseline | 8.71 ± 7.11 | 3.50 ± 7.34 |
Number of encounters with the UPMC healthcare system that include emergency room visits, provider calls, provider visits, procedures, and other treatments based on documentation within their medical record.
| Encounters | Multimodal Care Bundle | Usual Care |
|---|---|---|
| Emergency Room Visits | 2 | 5 |
| Provider Calls | 3 | 7 |
| Provider Visits | 18 | 8 |
| Procedures | 10 | 10 |
| Other Treatment (Pelvic Floor PT, bladder instillations, TENS unit for pain relief, etc) | 31 | 70 |
Collected over Entire study period; 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multimodal Care Bundle | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Usual Care | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Customized(Participants) | Multimodal Care Bundle | Usual Care | Total |
|---|---|---|---|
| Age Demographics — Ages 18-29 years | 7 | 4 | 11 |
| Age Demographics — Ages 30-42 years | 6 | 2 | 8 |
| Age Demographics — Ages 43-55 years | 2 | 3 | 5 |
| Age Demographics — Ages 56-68 years | 1 | 1 | 2 |
| Age Demographics — Ages 69+ years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Multimodal Care Bundle | Usual Care | Total |
|---|---|---|---|
| Female | 16 | 10 | 26 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Multimodal Care Bundle | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 15 | 10 | 25 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Multimodal Care Bundle | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 16 | 10 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body Mass Index (BMI)(Participants) | Multimodal Care Bundle | Usual Care | Total |
|---|---|---|---|
| Underweight: BMI < 18.5 | 0 | 0 | 0 |
| Healthy weight: BMI 18.5-24.9 | 6 | 4 | 10 |
| Overweight: BMI 25-29.9 | 2 | 4 | 6 |
| Obese: BMI >30 | 8 | 2 | 10 |
| Smoking Status(Participants) | Multimodal Care Bundle | Usual Care | Total |
|---|---|---|---|
| Current Smoker | 0 | 0 | 0 |
| Former Smoker | 2 | 0 | 2 |
| Never Smoked | 14 | 10 | 24 |
| Menopausal Status(Participants) | Multimodal Care Bundle | Usual Care | Total |
|---|---|---|---|
| Premenopausal | 14 | 8 | 22 |
| Postmenopausal, no HRT | 2 | 0 | 2 |
| Postmenopausal, HRT | 0 | 2 | 2 |
| Uncertain | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Estrogens · Methenamine · Amitriptyline · Gabapentin